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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Type  malfunction  
Event Description
It was reported to philips the doctor was shocked by the device.After a shock was sent to the patient the first time, then 15 seconds later, a shock was sent again while the doctor was working on the patient.Additional details have been requested.The doctor experienced a tingling shoulder but did not require treatment.There was no harm or injury to the doctor or to the patient.
 
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
laura scanlan
22100 bothell everett hwy
bothell, WA 98021
9786871501
MDR Report Key11190018
MDR Text Key228483899
Report Number1218950-2021-00330
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/23/2020
Initial Date FDA Received01/18/2021
Supplement Dates Manufacturer Received12/23/2020
Supplement Dates FDA Received03/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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